PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Jihad Obeid

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Jihad Obeid

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE)

Date Added
March 6th, 2023
PRO Number
Pro00125689
Researcher
Jihad Obeid

List of Studies


Keywords
Cholesterol, Dementia, Drug Studies, Geriatrics, Healthy Volunteer Studies, Heart, Memory Loss, Stroke Recovery
Summary

The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Amy Reynolds
(843) 792-8459
reynoamy@musc.edu

Transcranial Magnetic Stimulation for MCI: A Phase II Dose-Ranging Study

Date Added
March 21st, 2023
PRO Number
Pro00127160
Researcher
Andreana Benitez

List of Studies


Keywords
Aging, Alzheimers, Depression, Memory Loss
Summary

This is a Phase II research study to determine dosing of non-invasive brain stimulation for patients with Mild Cognitive Impairment (MCI) and current or past depression. The brain stimulation treatment used in this study is called repetitive transcranial magnetic stimulation (rTMS). rTMS is a Food and Drug Administration (FDA)-approved treatment for depression. The goal of the study is to see if brain stimulation can be used for MCI patients to improve memory, thinking, and mood, and what dose of stimulation works best.

The study uses a form of rTMS called intermittent theta burst rTMS (accelerated iTBS). This treatment has not been FDA-approved for MCI patients. This double-blind study requires 11 study visits over the course of six months.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu

RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Date Added
April 6th, 2023
PRO Number
Pro00128202
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with cancer in the stomach, esophagus, or gastroesophogeal junction. The study is being done to see if by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs is better or worse than the usual approach for treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II Study of INC280 (Capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
July 19th, 2023
PRO Number
Pro00130230
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This study is for patients who have advanced non-small cell lung cancer who in addition to the EGFR gene change (mutation) that was previously found in their tumor, testing found that their tumor also now has MET gene changes. The study is checking to see if a combination of 3 targeted drugs work together to lower the chance of lung cancer growing or spreading.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Date Added
July 30th, 2023
PRO Number
Pro00129939
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Date Added
January 9th, 2024
PRO Number
Pro00132012
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels

Date Added
January 23rd, 2024
PRO Number
Pro00131570
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Date Added
January 31st, 2024
PRO Number
Pro00130368
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This study is being done to learn more about apremilast (AMG 407) in mild to moderate plaque psoriasis in participants (children and adolescents) aged 6 to 17 years. It will see whether it causes any side effects. About 50 people are expected to take part in this study. The duration of the study is approximately 285 days. This includes 3 phases: 35 days of screening phase, 225 days (32 weeks) of treatment phase, and 60 days of observational follow-up phase after the last dose of study drug – this means drug is still being tested to see if it is safe and works.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu



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